The Safety of Reusing Walking Boot Components for Patients Recovering From Acute Foot and Ankle Injuries

NCT07287969 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 176418
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators primary purposes is to determine the safety of reusing a specific durable medical equipment (DME) item (walking boots) components for patients recovering from acute foot and ankle injuries. The investigators secondary purpose is to determine the number of reuse episodes specific walking boot components can endure without increased failure rates. To support further study of DME reuse, product design, and advocate for evolving regulations that promote waste reduction via development of reusable DME products in the US.

Conditions

Foot Injuries; Ankle Injuries

Keywords

Reusing Walking Boot; PROCARE MaxTrax 2.0, Air, Tall; PROCARE MiniTrax; Safety

Outcome Measures

Primary Outcomes (3)

• Rate of skin based complications (%)

  blisters, sores, erythema, rashes

  1-2 weeks after boot receipt

• Rate of skin based complications (%)

  blisters, sores, erythema, rashes

  4-weeks after boot receipt

• Rate of skin based complications (%)

  blisters, sores, erythema, rashes

  3 months after boot receipt

Study Arms (2)

New durable medical equipment (DME) walking boot

ACTIVE COMPARATOR

A patient will be randomized to the "new" boot arm of the study.

Device: New durable medical equipment (DME) walking boot

Re-used durable medical equipment (DME) walking boot

EXPERIMENTAL

A patient will be randomized to the "reuse" boot arm of the study.

Device: Re-used durable medical equipment (DME) walking boot

Interventions

Re-used durable medical equipment (DME) walking boot DEVICE

The patient will be randomized and fitted with their designated DME boot.

Also known as: PROCARE MaxTrax 2.0, Air, Tall, PROCARE MiniTrax

Re-used durable medical equipment (DME) walking boot

New durable medical equipment (DME) walking boot DEVICE

The patient will be randomized and fitted with their designated DME boot.

Also known as: PROCARE MaxTrax 2.0, Air, Tall, PROCARE MiniTrax

New durable medical equipment (DME) walking boot

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient is of ambulatory age
• Patient is ambulatory at baseline (i.e. prior to injury or intervention)
• Patient is recovering from an acute foot or ankle injury (bony or soft tissue)
• Patients expected to utilize the boot for \<12 weeks total
• Prescribed in the outpatient clinic setting only

You may not qualify if:

• Patients with ongoing infection, skin lesions, or wounds
• Immunosuppressed patients
• Patients with autism or behavioral concerns
• Non ambulatory patients
• Fitted and provided in the operating room or inpatient settings

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopedics

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Foot Injuries; Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Laura Bellaire, M.D.

  University of Utah Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 17, 2025
• Study Start: September 25, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)